Regulatory Publishing Associate

This role is responsible for the publication (electronically or paper) and distribution of regulatory submission and clinical trial dossiers, and the capture and reporting of regulatory product and registration information for company products.

Key Responsibilities:

Participates in the publishing of centrally supported regulatory dossiers for regulatory affairs category teams, either for direct submission to regulatory authorities, or for submission via local regulatory teams.

Participates in the publishing of R&D clinical study reports for the medical operations team.

Participates in submission activities and resource management of all assigned submissions / reports / documents in compliance with internal and external publishing quality standards.

Works in a collaborative effort with regulatory associates from central function and BUs to ensure assigned submission work is accomplished to agreed timings.

Prioritizes publishing work on dossiers and study reports in order to meet agreed regulatory targets. Work may be self-prioritized or may come from a more senior-level person in the group as part of a larger work plan.

Develops good working relationships with internal and external customers to facilitate effective communication and to ensure that customers adhere to publishing quality expectations and timelines with respect to the submission assembly and publication process.

Supports regulatory & medical customers to resolve publishing related issues, with support from senior management as required.

Provides advice and guidance on the production and publishing of regulatory submissions to R&D project teams, and regulatory affairs directly, to agree approaches and timelines for the supply of submission documents and data for submission preparation.

Contributes (as per assigned goals) to the evolution of publishing capability, including system enhancements, best-practice process improvements and regulatory intelligence.

Knowledge/ Education / Previous Experience Required:

Bachelor’s degree (or equivalent experience)

1 to 5 years’ experience in publishing of medicinal dossiers in electronic format; preferable in eCTD format

Care to join us. Find out what life at Haleon is really like

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

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